COVID-19 vaccinations
Conditions
Interventions
To describe the immune response in a cohort representative of the Dutch
population if boosted in autumn in order to provide data for Dutch
decisionmakers. Participants will be randomised into a Dire
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give written informed consent for participation in the trial. 2. Adult (male/female) between 18 and 65 years old. 3. Sufficient level of the Dutch language to undertake all study requirements . 4. HCW who work in the healthcare facility, without contra-indications, primed with janssen/Pfizer or Moderna and who had at least 1 boost.
Exclusion criteria
Exclusion criteria: 1. Adults younger than 18 or older than 65 years. 2. Adults primed with another vaccine than Janssen, Moderna or Pfizer. 3. History of allergic reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Janssen/Pfizer/Moderna vaccine). 4. Adults that are pregnant. 5. Currently being treated for cancer. 6. Severe kidney failure or dialyses dependent. 7. Status after organ-, stem cell- or bone marrow transplantation. 8. Use of immunosuppressant*s. 9. Epilepsy. 10. HIV. 11. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following IM injections of vene puncture. 12. Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc). 13. Participants who are currently participating in another research trial. 14. All regular contra-indications of the vaccines will be applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint The primary endpoint is to determine the fold change in antibody level at day of boost and 28 days after an additional COVID-19 booster vaccination in the direct boost group, comparing Janssen with mRNA-primed HCW. To specifically answer the key objective, we have defined two questions with the following outcome parameters: 1. Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine? Outcome: Level and fold change of antibodies determined by a quantitative IgG assay comparing the Janssen primed and mRNA-based primed HCW. 2. Does booster vaccination lead to a rapid recall response, indicative of immunological memory? Outcome: Level and fold change of antibodies and T-cell responses determined by a quantitative IgG assay and whole blood IFNγ release assay, respectively, comparing day 7 and 28 post-boost. Depending on whether it is possible to conduct this study with a bivalent vaccine, we will add an Omicron BA.1 IgG test to the arsenal of analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: In addition to the primary endpoints defined above, this study will address the following secondary objectives: 1. What is the difference in booster immunogenicity comparing a direct boost with a postponed boost? Outcome: Level of antibodies and T-cell responses 7 and 28 days post boost in DB versus PPB group. 2. What is the breadth of the immune responses after booster vaccination? Outcome: PRNT against relevant variants in a random selection of study participants. 3. What is the predictive value of immune responses on day 7 post boost? Outcome: Relationship between antibodies and T-cell responses on day 7 and 28 post boost. * 4. What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW? Outcome: Adverse events (AE) first 7 days after an additional boost between Janssen and mRNA primed HCW. 5. Initial examination of breakthrough infections before and during study period Outcome: Database of breakthrough infections in included participants based on positive PCR, self-reported positive lateral flow test, or detection of N-specific antibodies. 6. What is the difference in immunogenicity of the booster between the immediate boost and delayed boost group? Result: Level of antibodies and T cell responses at 7 and 28 days post boost in cohorts at different time points. | — |
Countries
Netherlands
Outcome results
None listed